Servier Pharmaceuticals LLC

The FDA approved Voranigo (vorasidenib) on August 6, 2024, as the first targeted treatment for Grade 2 IDH-mutant astrocytoma or oligodendroglioma in patients 12 years and older.

• The FDA is considering removing oral phenylephrine from its OTC Monograph due to a lack of efficacy as a nasal decongestant, potentially impacting numerous cold and allergy products. • Novartis' Scemblix expands its FDA-approved uses to include the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ PML). • Astellas Pharma's Vyloy (zolbetuximab) receives FDA approval as the first treatment targeting the CLDN18.2 protein for gastric or gastroesophageal junction adenocarcinoma. • Iterum Therapeutics' Orlynvah (sulopenem) gains FDA approval for treating uncomplicated urinary tract infections in women with limited oral antibacterial treatment options.

The FDA has approved the Ion Torrent Oncomine Dx Target Test as a companion diagnostic for vorasidenib in grade 2 astrocytoma or oligodendroglioma.

• The FDA has approved vorasidenib (Voranigo) as a systemic therapy for Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations. • Vorasidenib, developed by Servier Pharmaceuticals, targets the mutant IDH protein, reducing tumor size and delaying the need for other interventions like radiation or chemotherapy. • Clinical trials, including those at Duke University, showed that patients on vorasidenib experienced extended periods without tumor progression. • The approval marks a significant advancement, offering a targeted oral treatment that allows patients to maintain their quality of life during treatment.

Leading pharmaceutical companies including GSK, Schrödinger, and Insilico Medicine showcase how AI and machine learning are transforming the drug discovery process, with potential to create a $50 billion market in the next decade.

Vorasidenib, the first targeted therapy developed specifically for brain cancer, more than doubled progression-free survival in patients with recurrent grade 2 glioma carrying IDH1/IDH2 mutations, extending the time without disease progression from 11.1 months to 27.7 months.